Epidural Electrical Stimulation to Support Hemodynamic Management in Individuals With Parkinson's Disease

Официальное название

Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Support Hemodynamic Management in People With Typical and Atypical Parkinson's Disease

Обзор

The PD-HemON study aims to evaluate the safety and preliminary efficacy of ARC-IM Therapy (Epidural Electrical Stimulation) to support hemodynamic management in people with typical and atypical Parkinson's Disease, who suffer from orthostatic hypotension.

Вмешательства

• Устройство ARC-IM Investigational System
  Implantation of a stimulation lead on the low thoracic level of the spinal cord and implantation of a neurostimulator in the abdominal region.

Первичные конечные точки

• Occurrence of (serious) adverse device effects of the ARC-IM Therapy from baseline up to the end of the study. [Срок оценки: Throughout the study (up to 5 years)]

Вторичные конечные точки (8)

• 10-minute, orthostatic head-up tilt test with and without the ARC-IM Therapy at 1 month after intervention [Срок оценки: At the end of, 6 months after and 1 year after configuration of the therapy,]
• Severity of symptoms measured by The Orthostatic Hypotension Questionnaire. [Срок оценки: At the end of, 6 months after and 1 year after configuration of the therapy]
• Time Up and Go Test (TUG) [Срок оценки: At the end of, 6 months after and 1 year after configuration of the therapy]
• 2 Minute Walk Test [Срок оценки: At the end of, 6 months after and 1 year after configuration of the therapy]
• Berg Balance Test [Срок оценки: At the end of, 6 months after and 1 year after configuration of the therapy]
• Quebec User Evaluation of Satisfaction with technology (QUEST 2.0) [Срок оценки: At 6 months and 1 year after configuration of the therapy]
• System Usability Scale (SUS) [Срок оценки: At 6 months and 1 year after configuration of the therapy]
• Additional user feedback of ARC-IM System [Срок оценки: At 6 months and 1 year after configuration of the therapy]

Критерии участия

Критерии включения

• > 18 years old
• Typical or Atypical PD (including but not limited to Multiple System Atrophy, Pure Autonomic Failure, Progressive Supranuclear Palsy)
• Confirmed orthostatic hypotension with a test for verticalization
• Confirmed symptomatic orthostatic hypotension that makes daily activities particularly challenging as determined by the study clinicians
• Must provide and sign the Informed Consent before any study-related procedures
• Stable medical, physical, and psychological conditions given participant indication as considered by Investigators;
• Able to understand and interact with the study team in French or English
• Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments

Критерии исключения

• Diseases and conditions that would increase the morbidity and mortality of the implantation surgery
• The inability to withhold antiplatelet/anticoagulation agents perioperatively
• History of myocardial infarction or cerebrovascular events within the past 6 months
• Unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations as determined by the Investigator
• History or presence of major psychiatric disorders or major neurocognitive disorders as considered by the Investigators in accordance with the treating physician and treating neurologist
• Major changes in PD treatment planned until the end of the main study phase (such as DBS or dopamine-pump implantation)
• Inability to follow study procedures.
• Spinal anatomical abnormalities precluding surgery
• Presence of any indications requiring frequent MRIs.
• Current pregnancy or current breastfeeding
• Lack of effective or acceptable contraception for women of childbearing capacity
• Intention to become pregnant during the study
• Unable or unwilling to effectively use the study system or related devices by the participant or caretaker, as determined by the investigator
• Participation in another interventional study that might confound study endpoint evaluations
• Enrolment of the investigator, his/her family members, employees, and other dependent persons

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• CHUV — Lausanne

Идентификаторы

NCT: NCT06920134 · PD-HemON · HT94252410901 · CDMRP-PD230100

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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